NCT05089903

Brief Summary

This project aims to evaluate different approaches to increase breast cancer screening among primary care patients at Penn Medicine through a centralized screening outreach program. In a pragmatic trial, the investigators will evaluate different approaches to increase completion of screening among eligible patients, including ordering mammograms in bulk prior to outreach, sending personalized text reminders, and endorsing of the communication by the primary care provider.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24,680

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 8, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 22, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

October 25, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2022

Completed
Last Updated

June 27, 2022

Status Verified

June 1, 2022

Enrollment Period

3 months

First QC Date

October 8, 2021

Last Update Submit

June 24, 2022

Conditions

Breast Cancer

Keywords

MammographyPreventive ScreeningPopulation Health

Outcome Measures

Primary Outcomes (1)

  • Mammogram Completion in 3 months

    Percent of patients that complete a mammogram

    3 months

Secondary Outcomes (1)

  • Mammogram Completion in 6 months

    6 months

Other Outcomes (7)

  • Mammogram Positivity Rate

    3 months

  • Mammogram Completion by Age Groups

    3 months

  • Mammogram Completion by Race/Ethnicity

    3 months

  • +4 more other outcomes

Study Arms (8)

No Order

EXPERIMENTAL
Behavioral: No Bulk Order

No Order + Text (NO+T)

EXPERIMENTAL
Behavioral: TextingBehavioral: No Bulk Order

Bulk Order (BO)

EXPERIMENTAL
Behavioral: Bulk Order

Bulk Order + Text (BO+T)

EXPERIMENTAL
Behavioral: Bulk OrderBehavioral: Texting

Clinician Endorsement (CE)

EXPERIMENTAL
Behavioral: Clinician Endorsement

Clinician Endorsement + Text (CE+T)

EXPERIMENTAL
Behavioral: TextingBehavioral: Clinician Endorsement

Standard Messaging (SM)

EXPERIMENTAL
Behavioral: Standard Endorsement

Standard Messaging (SM+T)

EXPERIMENTAL
Behavioral: TextingBehavioral: Standard Endorsement

Interventions

Bulk OrderBEHAVIORAL

A mammogram order will be placed using bulk order technology in the EHR in advance of outreach for all patients.

Bulk Order (BO)Bulk Order + Text (BO+T)
TextingBEHAVIORAL

In addition to outreach, patients will receive text messaging with information regarding the importance of screening, how to schedule a mammogram, and locations available for mammography.

Bulk Order + Text (BO+T)Clinician Endorsement + Text (CE+T)No Order + Text (NO+T)Standard Messaging (SM+T)
Clinician EndorsementBEHAVIORAL

Outreach informing patients that they are overdue for a mammogram will be signed by the patient's primary care provider.

Clinician Endorsement (CE)Clinician Endorsement + Text (CE+T)
No Bulk OrderBEHAVIORAL

The outreach will ask patients to contact their PCP's office in order to have a mammogram order placed on their behalf.

No OrderNo Order + Text (NO+T)
Standard EndorsementBEHAVIORAL

Patient's will receive outreach from the practice informing them that they are overdue for a mammogram.

Standard Messaging (SM)Standard Messaging (SM+T)

Eligibility Criteria

Age40 Years - 74 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women ages 40-74
  • Followed by Primary Care with a Penn Medicine PCP listed and at least one visit in the last 2 years
  • Health Maintenance due (default biannual screening starting at age 50 or edit modifier based on input by clinician)

You may not qualify if:

  • Currently scheduled for a mammogram
  • History of bilateral mastectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • Mehta SJ, Rhodes C, Linn KA, Reitz C, McDonald C, Okorie E, Williams K, Resnick D, Arostegui A, McAuliffe T, Wollack C, Snider CK, Peifer MK, Weinstein SP. Behavioral Interventions to Improve Breast Cancer Screening Outreach: Two Randomized Clinical Trials. JAMA Intern Med. 2024 Jul 1;184(7):761-768. doi: 10.1001/jamainternmed.2024.0495.

    PMID: 38709509DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Shivan Mehta, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SCREENING
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 8, 2021

First Posted

October 22, 2021

Study Start

October 25, 2021

Primary Completion

January 25, 2022

Study Completion

April 25, 2022

Last Updated

June 27, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)